(86 days)
MAS® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaving for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
Moni-Trol® PTH Control is intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring assay conditions in many Parathyroid hormone (PTH) determinations. Include PTH Control with patient serum specimens when assaving for Parathyroid hormones. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.
This product is a liguid stable control material prepared from human serum. Analyte levels are adjusted with various pure chemicals and preparations from human tissue or bodily fluids. Preservatives and stabilizers are added to maintain product integrity.
The provided text is a 510(k) summary for a medical device called MAS® PTH Control and Moni-Trol® PTH Control. This document primarily focuses on establishing substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the context of clinical performance or diagnostic accuracy.
The device is a quality control material for monitoring assay conditions for Parathyroid hormone (PTH) determinations. Its primary function is to assure consistent performance of reagents and instruments, not to directly diagnose or screen patients. Therefore, the types of acceptance criteria and studies typically associated with diagnostic algorithms (e.g., sensitivity, specificity, clinical outcome studies, multi-reader multi-case studies) are not applicable or described for this type of device.
Here's a breakdown of why the requested information isn't present in the provided text:
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Acceptance criteria and reported device performance: These are not detailed in the context of clinical accuracy metrics, as the device is a control material. The "Comparison of Technological Characteristics" table presents differences in intended use, description, matrix, form, storage conditions, stability, and analytes compared to the predicate device. For a control, performance is typically assessed by its stability, consistency, and ability to provide expected values when tested with various assay systems, allowing laboratories to monitor the performance of those assays. These types of performance characteristics are generally verified internally by the manufacturer through analytical studies (e.g., precision, accuracy, linearity) but are not explicitly presented as "acceptance criteria" against which a device's clinical performance is measured in this summary.
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Sample size for the test set and data provenance: Not applicable. There is no "test set" in the sense of patient data used to evaluate a diagnostic algorithm. Performance would be assessed through internal analytical testing of the control material itself (e.g., stability studies, homogeneity studies), not a clinical test set.
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Number of experts and qualifications for ground truth: Not applicable. Ground truth for a control material would be its assigned value, determined by the manufacturer based on target analytes and reference methods, not by expert consensus on clinical cases.
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Adjudication method for the test set: Not applicable.
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Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study is for evaluating the impact of an AI algorithm on human reader performance for diagnostic tasks. This device is a quality control.
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Standalone performance study: Not applicable in the sense of an algorithm's diagnostic performance. The "performance" of this device relates to its ability to serve as a reliable control.
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Type of ground truth used: For a quality control material, the "ground truth" is the established reference value for the analyte within the control, which is determined by the manufacturer using validated methods.
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Sample size for the training set: Not applicable. This is not an AI algorithm that requires a training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) summary focuses on the regulatory aspects of introducing a new quality control material, primarily demonstrating its substantial equivalence to an existing predicate device based on its intended use, technological characteristics, and performance as a control. It does not contain the information requested regarding acceptance criteria and clinical study results that would be relevant for a diagnostic or screening device.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.